Tele Health Monitoring Service for Patients With Chronic Obstructive Pulmonary Disease

NCT02615795 | Completed DMC

• 1 other identifier: UAarhusFA
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effect of monitoring patients with chronic obstructive pulmonary disease (COPD) after a hospitalization for COPD exacerbation or pneumonia. The patients are randomized to receive either standard treatment and follow up, or standard treatment and follow up, plus tele monitoring of key clinical parameters and symptoms for six months.

Conditions

Chronic Obstructive Pulmonary Disease, COPD

Outcome Measures

Primary Outcomes (1)

• Number of hospitalization days

  During twelve months

Secondary Outcomes (9)

• Duration of COPD related hospitalizations, in days

  Twelve months

• Number of hospitalizations caused by COPD exacerbation

  During twelve months

• Number of COPD related contacts to emergency rooms

  Twelve months

• Number of self-addressed COPD exacerbations

  Twelve months

• Sensitivity of physiological measurements in detecting COPD exacerbation

  During six months of intervention

Study Arms (2)

Control

NO INTERVENTION

Best practice

Intervention

EXPERIMENTAL

Best practice + Tele Monitoring of physiological parameters (heart frequence, oxygen saturation, weight, FEV1), and answers to disease specific questions, using Tunstall monitoring device.

Device: Tele Monitoring, using Tunstall monitoring device

Interventions

Tele Monitoring, using Tunstall monitoring device DEVICE

Monitoring of symptoms and physiological parameters at home, using Tunstall Healthcare telemedicine equipment. Patients perform physiological measurement. In addition, they correspond to a standardized questionnaire regarding disease specific symptoms. Data is assessed by the medical staff the same day. If the data indicates worsening in the patient's condition, the patient is contacted by phone. The assessment of the patient is made either on the specialist nurse level, or at a conference between the specialist nurse and a senior pulmonary doctor. There is no call center service.

Also known as: Tunstall monitoring device

Intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Not able to give written or oral consent
• Terminal disease, such as cancer
• Unstable heart disease, such as coronary infarction within the last to month
• Disabling psychiatric disease
• Asthma
• Inability to use the equipment
• Severe language barriers
• Drug abuse
• Alcohol abuse

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Region Hospital of Silkeborg

Silkeborg, Mid Region, 8600, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frank D Andersen, MD

  Diagnostic Center, Regional Hospital of Silkeborg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 26, 2015
• Study Start: March 1, 2011
• Primary Completion: June 6, 2018
• Study Completion: June 6, 2018
• Last Updated: October 2, 2019

Record last verified: 2010-10

Locations

DK (1)